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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 402 drug applications between 18 December 2025 and 24 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 76, covering 52 drug names.

2025/12/18 – 2025/12/24

Period
2025/12/18 to 2025/12/24, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
402
Drugs with new generic filings (by drug name, de-duplicated)
52
Accepted this week, now under review
82

DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.

Names with a public page are linked.

New acceptances this week

By application type and drug type

402filings, 76 of them generic

By application type

Application typeFilings
Supplement202
New drug91
Generic76
Unspecified15
Import11
Import re-registration7

By drug type

Drug typeFilings
Chemical drug191
TCM123
Therapeutic biologic79
Biologic5
Prophylactic biologic4

DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.

Most new generic filings, by drug

52 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Baricitinib Tablets3232
2Lidocaine and Prilocaine Cream3124
3Sildenafil Citrate Tablets3112
4Oseltamivir Phosphate Capsules3139
5草酸艾司西酞普兰口服溶液 · No verified English name3111
6西诺氨酯片 · No verified English name3124
7Colistimethate Sodium for Injection222
8Glucosamine Sulfate Capsules2251
9Ilaprazole Enteric-coated Tablets2226
10利伐沙班口崩片 · No verified English name214

DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.

Most new acceptances, by company

217 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Sheng De Shang Pharma Co., Ltd. romanized46390
2Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized14140
3Amgen Inc.1210
4Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized1020
5Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized550
6Merck Sharp & Dohme LLC530
7Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized535
8Name not romanized520
9Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized520
10Beijing Lian Er Tang Pharma Co., Ltd. romanized440

DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.

Under-review list changes

Compared across this platform's snapshots of the under-review list

Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.

DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

121 this week

AcceptedDrugApplicants
2025/12/24Import · Class 1 戈鲁利单抗注射液 · No verified English nameJXSS2500153 Alexion Europe SAS; Patheon Italia S.P.A.; AstraZeneca Global R&D (China) Co. Ltd.
2025/12/24Import · Class 1 戈鲁利单抗注射液 · No verified English nameJXSS2500152 Alexion Europe SAS; Patheon Italia S.P.A.; AstraZeneca Global R&D (China) Co. Ltd.
2025/12/24Import · Class 1 DAK539片 · No verified English nameJXHL2500391 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/12/24Import · Class 1 DAK539片 · No verified English nameJXHL2500390 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/12/24Generic · Class 3 Betaine anhydrous for oral solutionCYHS2504363 Beijing Si Li An Pharma Co., Ltd. romanized
2025/12/24Generic · Class 3 奥美拉唑镁/阿莫西林/利福布汀肠溶胶囊 · No verified English nameCYHL2500229 Shandong Qidu Pharmaceutical Co., Ltd.
2025/12/24New drug · Class 1.1 KLN01颗粒 · No verified English nameCXZL2500134 Nanjing Ke Ling Pharmaceuticals Technology Co., Ltd. romanized
2025/12/24New drug · Class 2.3 虚汗停颗粒 · No verified English nameCXZL2500133 Guangzhou Bai Yun Shan Qi Xing Pharma Co., Ltd. romanized
2025/12/24New drug · Class 1 莱康奇塔单抗注射液 · No verified English nameCXSS2500144 Zhuhai Shi Li Zhu Dan Kang Bio Technology Co., Ltd. romanized
2025/12/24New drug · Class 1 GO321重组溶瘤痘苗病毒注射液 · No verified English nameCXSL2501123 Shanghai Jin Si Bio Technology Co., Ltd. romanized
2025/12/24New drug · Class 1 TQB6457注射液 · No verified English nameCXSL2501122 Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2025/12/24New drug · Class 1 注射用VRT106 · No verified English nameCXSL2501121 Guangzhou Wei Rong Te Pharmaceuticals Technology Co., Ltd. romanized
2025/12/24New drug · Class 2.2; 2.4 注射用KJ101 · No verified English nameCXSL2501119 Shanghai Bao Ji Pharma Co., Ltd. romanized
2025/12/24New drug · Class 1 SHR-3836注射液 · No verified English nameCXSL2501118 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/12/24New drug · Class 1 SHR-3836注射液 · No verified English nameCXSL2501117 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/12/24New drug · Class 1 酒石酸凡瑞格拉替尼片 · No verified English nameCXHS2500162 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized
2025/12/24New drug · Class 2.3 BCM894胶囊 · No verified English nameCXHS2500161 Hainan Jin Rui Bao Pharmaceuticals Technology Co., Ltd. romanized; Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized
2025/12/24New drug · Class 1 RBD5044注射液 · No verified English nameCXHL2501448 Rui Bo Tai Ke (Shandong) Biopharmaceuticals Technology Co., Ltd. romanized
2025/12/24New drug · Class 1 108MCN鼻喷雾剂 · No verified English nameCXHL2501447 Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Shuo Bai Pharmaceutical Co., Ltd. romanized
2025/12/24New drug · Class 1 CMS-D008注射液 · No verified English nameCXHL2501446 Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized
2025/12/23Import · Class 1 Frexalimab注射液 · No verified English nameJXSL2500245 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2025/12/23Generic · Class 3 Haloperidol Oral SolutionCYHS2504360 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2025/12/23Generic · Class 3 Paracetamol And Ibuprofen Oral SuspensionCYHS2504357 Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/12/23Generic · Class 3 贝美前列素涂剂 · No verified English nameCYHL2500228 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.
2025/12/23Generic · Class 3 Colistimethate Sodium for InjectionCYHL2500227 Hebei Sheng Xue Da Cheng Pharmaceutical Co., Ltd. romanized
2025/12/23Generic · Class 3 氟[18F]妥西吡注射液 · No verified English nameCYHL2500226 Hangzhou Yi Li Pharmaceuticals Co., Ltd. romanized
2025/12/23New drug · Class 3.3 QL2109注射液 · No verified English nameCXSL2501120 Qilu Pharmaceutical Co., Ltd.
2025/12/23New drug · Class 1 JWK001注射液 · No verified English nameCXSL2501116 Chengdu Jin Wei Ke Bio Technology Co., Ltd. romanized
2025/12/23New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2501115 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2025/12/23New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2501114 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized

91 more not listed (at most 30 rows).

DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.

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